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临床试验/NCT00934973
NCT00934973已完成4 期

Management of Irritable Bowel Syndrome in Primary Care: Feasibility Randomised Controlled Trial of Mebeverine, Methylcellulose, Placebo and a Patient Self-management Cognitive Behavioural Therapy Website. (MIBS Trial)

Hazel Everitt1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Hazel Everitt
入组人数
135
试验地点
1
主要终点
IBS Symptom Severity Score

研究概览

简要总结

Aims:

  1. To pilot an randomized, controlled trial (RCT) to assess the effectiveness of the commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose (bulking-agent) and of the patient CBT based self-management website.
  2. To assess the level of support needed for patients using the patient CBT based self-management website for IBS (i.e., initial 30 minute telephone support session with a nurse and email support or not).

详细描述

Background:

Irritable bowel syndrome (IBS) affects 10-22% of the United Kingdom (UK) population, with National Health Service (NHS) costs over £200 million a year. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current general practitioner (GP) treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many suffer ongoing symptoms.

A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are widely used: NHS costs 2005 of nearly £10 million for mebeverine and over £8 million for fiber-based bulking agents.

Cognitive behavioral therapy (CBT) and self-management can be helpful, but poor availability in the NHS restricts its use. Development of web-based CBT could increase access without increased costs.

Plan of Investigation:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 16 to 60 years with symptoms of irritable bowel syndrome that fulfill the Rome III criteria

排除标准

  • Atypical symptoms (unexplained weight loss, rectal bleeding)
  • Diagnosis of inflammatory bowel disease, coeliac disease or peptic ulcer disease
  • Pregnant or breast feeding
  • Currently taking or allergy to mebeverine or methylcellulose

研究组 & 干预措施

mebeverine + no website

Active Comparator

Mebeverine 135mg tds for 6 weeks

干预措施: mebeverine (Drug)

mebeverine + no website

Active Comparator

Mebeverine 135mg tds for 6 weeks

干预措施: No website (Behavioral)

methylcellulose + no website

Active Comparator

methylcellulose 3 tablets twice a day for 6 weeks

干预措施: methylcellulose (Drug)

methylcellulose + no website

Active Comparator

methylcellulose 3 tablets twice a day for 6 weeks

干预措施: No website (Behavioral)

placebo + no website

Placebo Comparator

placebo tablets

干预措施: placebo (Drug)

placebo + no website

Placebo Comparator

placebo tablets

干预措施: No website (Behavioral)

mebeverine + CBT website minimal support

Active Comparator

mebeverine 135mg tds and access to website

干预措施: mebeverine (Drug)

mebeverine + CBT website minimal support

Active Comparator

mebeverine 135mg tds and access to website

干预措施: CBT website with minimal support (Behavioral)

methylcellulose + CBT website

Active Comparator

methylellulose 3 tablets twice a day and access to website

干预措施: methylcellulose (Drug)

methylcellulose + CBT website

Active Comparator

methylellulose 3 tablets twice a day and access to website

干预措施: CBT website with minimal support (Behavioral)

placebo + CBT website minimal support

Placebo Comparator

placebo tablets and access to website

干预措施: placebo (Drug)

placebo + CBT website minimal support

Placebo Comparator

placebo tablets and access to website

干预措施: CBT website with minimal support (Behavioral)

mebeverine + CBT website with support

Active Comparator

mebeverine 135mg tds and access to website with nurse support session

干预措施: mebeverine (Drug)

mebeverine + CBT website with support

Active Comparator

mebeverine 135mg tds and access to website with nurse support session

干预措施: CBT website with support (Behavioral)

methylcellulose + CBT website support

Active Comparator

methylcellulose 3 tablets twice a day and access to website with nurse support

干预措施: methylcellulose (Drug)

methylcellulose + CBT website support

Active Comparator

methylcellulose 3 tablets twice a day and access to website with nurse support

干预措施: CBT website with support (Behavioral)

placebo + CBT website with support

Placebo Comparator

placebo tablets and access to website with nurse support

干预措施: placebo (Drug)

placebo + CBT website with support

Placebo Comparator

placebo tablets and access to website with nurse support

干预措施: CBT website with support (Behavioral)

结局指标

主要结局

IBS Symptom Severity Score

时间窗: Baseline, 6 and 12 weeks

IBS QOL

时间窗: Baseline, 6 and 12 weeks

Quality of life

次要结局

  • HADs(Baseline, 6 and 12 weeks)
  • Enablement(6 and 12 weeks)
  • Subjects Global Assessment of relief(6 weeks and 12 weeks)

研究者

发起方
Hazel Everitt
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hazel Everitt

Principal Investigator

University of Southampton

研究点 (1)

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